Cleared Traditional

K851565 - HOMEDICA CEMENTED ACETABULAR COMPONENT ...

K851565 is the FDA 510(k) clearance for HOMEDICA CEMENTED ACETABULAR COMPONENT ... by Howmedica Corp.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K851565 · Howmedica Corp. · Cardiovascular device
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Jul 1985
Decision
94d
Days
Class 2
Risk

K851565 is an FDA 510(k) clearance for the HOMEDICA CEMENTED ACETABULAR COMPONENT 6262. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 19, 1985 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

Submission Details

510(k) Number K851565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date July 19, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 73
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K851565.
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
K874939 · Kirschner Medical Corp. · Feb 1988
POROCOAT SCHATZKER II ACETABULUM
K852193 · Depuy, Inc. · Jul 1985
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964 · Howmedica Corp. · Jul 1985
FREEMAN ACETABULAR CUP
K823843 · Depuy, Inc. · Mar 1983
AUFRANC-TURNER ATS METAL BACKED ACETABU
K830097 · Howmedica Corp. · Jan 1983
ONE HAND ANEROID SPHYGMOMANOMETER
K821232 · Abco Dealers, Inc. · May 1982